98 Chapter 7 September 2017 and a minimum follow-up of 6 months was determined. Patients in whom an autologous adjunctive procedure was used were excluded. Variables for risk factor analysis The following patient characteristics were used in univariable and multivariable analyses: age in years (continuous), body mass index (BMI, continuous), American Association of Anesthesiologists (ASA) grade (1-2 and 3-4) and active smoking (yes or no). Furthermore, surgery characteristics involved: indication for surgery (breast cancer or prophylactic surgery), previous radiotherapy (yes or no), preoperative antibiotics (yes or no), antiseptic rinse (yes or no, if yes: using an antiseptic (betadine) solution, an antibiotic solution or a combination of an antiseptic and antibiotic solution), nipple guards (yes or no), nipple preserving procedure which was derived from incision site (yes or no, if yes: mastectomy scar - nipple sparing, inframammary, periareolar and axillary incisions, if no: mastectomy scar - general), type of reconstruction (TE or permanent implant), prepectoral placement (yes or no, if no: partial or complete cover with pectoralis major muscle), concurrent mastopexy (yes or no), postoperative drains (yes or no), volume of permanent implant (continuous), maximum volume of TE (continuous), intraoperative volume TE in cubic centimeters (<100, 100-200 or >200), postoperative antibiotics (yes or no) and adjuvant radiotherapy (yes or no). Outcome measures and definitions The outcome of interest was implant loss, which was defined as explantation of the implant due to postoperative wound healing-related complications within 6 months after placement. The following available variables in the DBIR were considered implant loss: (1) explantation of the implant (TE or permanent implant) or replacement of the implant (TE or permanent implant) with TE due to flap problems, infection, skin necrosis, hematoma, seroma or if no reason was provided. (2) Replacement of implant (TE or permanent implant) with permanent implant because of flap problems, infection, skin necrosis, hematoma or seroma. (3) Replacement of implant (TE or permanent implant) with autologous tissue combined with flap problems, infection or skin necrosis. Other indications for revision or explantation (dissatisfaction with size, asymmetry, breast pain, breast implant associated illness (BII), suspected or confirmed anaplastic large cell lymphoma (ALCL), newly diagnosed breast cancer, device malposition, scarring, capsular contracture or device rupture) were not included in the definition. Statistical analysis Statistical analysis was performed using SPSS (version 26 IBM Corp, Armonk, NY). A two-sided P-value of <0.05 was considered statistically significant. For continuous
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